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Regulatory Affairs Support
We handle all submissions to regulators and will make sure your clinical trial is compliant throughout the project to keep timeline on track.
Regulatory Affairs & Compliance Support (Phase I-IV)
Regulatory documentation and compliance are paramount in clinical trials to ensure that all submissions and approvals are conducted in accordance with required regulations. While undertaking clinical trials from Phases I-IV, the trials must remain compliant to an evolving array of local and international regulations in preparing the Clinical Trial Applications (CTA) to a final report.
Our support service will assist in ensuring the documentation is prepared and submitted to avoid delays and limits failure to comply,
ensuring your trials are not delayed, while you’ll experience a smoother regulatory process that leads to greater timeliness, compliance, and reduced cost of delays.
At Statswork, we offer complete regulatory support to prepare and manage your submissions and approvals. Our regulatory services will work with regulators so you will receive timely update while remaining compliant for a timely execution of the clinical trial through multiple phases.
Supporting Regulatory Compliance in Clinical Trials
In all phases of your trial, Statswork will maintain accurate and timely submission of regulatory documents assuring your clinical trial meets international regulations and minimizes time delays.
Enhancing Compliance While Reducing Approval Timelines
Stat’s approach to regulatory documentation streamlining timelines for regulatory approval enhances compliance and progress of the trial enhancing ROI and efficacy of the trial.
Providing Expertise and Regulatory Assurance
This is professionally resolved so you can have the peace-of-mind that all aspects of regulatory documentation will be managed by us and have assurance you are compliant with the regulatory bodies.
Regulatory Documentation and Compliance
We are responsible for all regulatory submissions and will make sure your trial remains compliant with applicable international standards, from CTAs to final reports. In doing so, we will work to keep you on schedule and will help avoid delays in your trial’s progress.
Risk Mitigation and Compliance
Our timely and accurate documentation has been shown to reduce regulatory risk, expedite the approval process, and assist you to keep your trial on track.
Regulatory Expertise Support
We offer regulatory expertise support in the preparation and submission of all regulatory documents, ensuring you remain fully compliant and audit-ready, at all phases of the trial.
Regulatory Strategy and Consulting
We provide strategic consulting on how to navigate complex regulatory environments, sharing and advising you on submission processes, timelines, and requirements to ensure your trial is compliant with regulatory expectations as efficiently as possible.
Our Industry
At Statswork, we help pharmaceutical, biotechnology, and healthcare companies navigate regulatory documentation and compliance throughout all phases of clinical trials (I-IV). Our services ensure all submissions meet regulatory standards, reducing risks and streamlining approval processes.
Streamline Trials
We handle the regulatory submissions for you, minimizing delays and facilitating the trial process, leading to a quicker time to market.
Compliance and Risk Mitigation
Your team has peace of mind knowing that we ensure far-reaching, timely favourable regulatory submissions that comply with global standards, each step of the trial is compliant and ready for audit at any time.
Leverage Global Markets
We develop accurate regulatory documentation for clinical trials in order to create a seamless submission internationally allowing you to enter the global market with your trial quicker.
1. Regulatory Strategy and Submission Management
We coordinate all regulatory submissions, comply with global standards (FDA, EMA, and ICH), and receive all needed approvals for your trial on time.
2. Regulatory Documentation Preparation
Our team prepares and submits all necessary regulatory documentation, including a trial protocol and safety reports, to ensure accuracy and compliance.
3. Audit-Ready Reports
We generate audit-ready tables and summaries of analysis, making communication with health authorities more straightforward while ensuring the regulatory compliance of your global trial.
4. Regulatory Compliance Monitoring
The trial's regulatory documents will be monitored and revised as necessary to meet evolving regulatory standards at the global level.
5. Global Regulatory Consultation
We provide global and regulatory consultation relating to navigating complex requirements so that your trial is ready for global engagement.
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